Otc - Active Ingredient
Sodium Monofluorophosphate - .76%
(Total Fluoride Content - 1000 ppm Approx.)
Freshmint Anticavity Fluoride Paste, Dentifrice
FDA Label NDC 51824-067
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Freshmint Anticavity Fluoride (NDC 51824-067). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children under 6 years of Age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Helps protect against cavities
Warnings
Keep out of reach of children under 6 years of age.
Dosage & Administration
Adults and Children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years: Ask a dentist of physician.
Inactive Ingredient
Calcium Carbonate, Treated Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methylparaben, Titanium Dioxide, Polyethylene Glycol 400, Propylparaben
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